A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.
Conditions:
🦠 Obesity 🦠 Ulcerative Colitis
🗓️ Study Start (Actual) 20 September 2023
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * BMI 30-50 kg/m2 for at least 6 months prior to ESG
    • * Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
    • * Willing to adhere to the diet and behavior modifications required for ESG
    • * Able to follow the visit schedule
    • * Able to provide informed consent
    • * If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline

    Exclusion Criteria:

    • * Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
    • * Current or recent (last six months) gastric or duodenal ulceration
    • * Esophageal or gastric varices
    • * Significant motility disorder of the esophagus or stomach
    • * Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
    • * Severe coagulopathy, hepatic insufficiency, or cirrhosis
    • * Gastric mass
    • * Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease
    • * Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits
    • * Unwilling to participate in an established diet and behavior modification program, with routine follow-up
    • * Ongoing corticosteroid use at a dose of \>5 mg daily
    • * Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision
    • * Alcohol or drug addiction
    • * Females who are pregnant, nursing, or planning pregnancy within the next year
    • * Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
    • * Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Ages Eligible for Study: 22 Years to 69 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 February 2023
  • First Submitted that Met QC Criteria 13 February 2023
  • First Posted 22 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 October 2023
  • Last Update Posted 19 October 2023
  • Last Verified October 2023